Welcome!

@CloudExpo Authors: Xenia von Wedel, Dana Gardner, Elizabeth White, Peter Galvin, Liz McMillan

News Feed Item

Pharmaceutical and IT Communities Collaborate on OASIS Clinical Trial Data Standard for Content Management Systems

The pharmaceutical community, health care organizations, and software providers are coming together at the OASIS open standards consortium to define a machine-readable content classification standard for the interoperable exchange of clinical trial data via content management systems. The work of the new OASIS Electronic Trial Master File (eTMF) Standard Technical Committee will promote interoperability across diverse computing platforms and cloud networks within the clinical trials community.

“We’re responding to a growing global need for a technology standard that can support formal representation and exchange of clinical trials eTMF content. Our goal is to enhance information interoperability among stakeholders,” said Zack Schmidt of SureClinical, chair of the OASIS eTMF Standard Technical Committee. “The breadth and stature of the organizations advancing this work clearly indicate there’s a real need for this standard.”

The OASIS eTMF work will enable content to be exchanged through cloud, networks, or physical media. Members will define an eTMF content classification model (including a standards-based vocabulary and content classification ontology), a set of content classification policies, and an eTMF Data Model.

The eTMF Standard framework will be a 'standard based on standards.’ It will support required documents from multiple regulatory agencies, published vocabulary references, and key industry standards. The OASIS work will be take place in two phases. The technology phase will build on the content classification specification and core terms contributed to OASIS by CareLex with input from the National Cancer Institute’s Enterprise Vocabulary Services. The vocabulary phase will build on the TMF Reference Model produced by the Document and Records Management DIA Community. It will utilize a W3C semantic web-based ontology to classify content as well as a controlled vocabulary sourced primarily from the NCI Thesaurus, which includes terms from the Biomedical Research Integrated Domain Group (BRIDG) Model, the product of a collaboration among CDISC, NCI, HL7, and the U.S. FDA. Additional eTMF domain classification terms, some of which are not present in BRIDG, will be developed by the OASIS Technical Committee.

New members are encouraged to join the OASIS eTMF Standard Technical Committee at any time. Archives of the work are accessible to both members and non-members, and OASIS invites public review and comment on the work.

Support for OASIS eTMF Standard

Forte Research Systems
“As a provider of specialized software serving organizations engaged in clinical and translational research, Forte Research Systems is committed to the development and adoption of relevant technology standards like eTMF and to supporting the work of standards organizations like OASIS. We are particularly enthusiastic about this new OASIS effort because it promises a consistent organization and structure of TMF content enabling the exchange of common TMF elements with other software systems in this space.”
--Tony O'Hare, PhD, Co-Founder, VP Operations, & Chief Collaboration Office, Forte Research

Health Level Seven (HL7)
“HL7 is pleased to continue its collaborative efforts with OASIS by participating in the Electronic Trial Master File (eTMF) Standard. This initiative to support formal representation and exchange of clinical trials eTMF information is well aligned with the existing standard that was jointly developed by HL7 and CDISC for the Regulated Clinical Research Information Management (RCRIM) Biomedical Research Integrated Domain Group’s Domain Analysis Model for the clinical research domain and also leverages a long standing HL7 relationship with not only CDISC and OASIS but also the FDA and NLM.”
--John Quinn, CTO, HL7

Oracle
“As a leading provider of life science solutions, Oracle recognizes that developing standards to support data exchange and interoperability is critical to the smooth flow of data between systems that participate in the clinical trial life cycle. The ability for eTMF systems to easily consume Trial Master File documents and exchange those documents seamlessly will greatly improve sponsor management of trial documentation and speed up preparation of trial artifacts used in regulatory submissions. Oracle is pleased to participate in this initiative.”
--Don Deutsch, VP, Chief Standards Officer, Oracle

SureClinical
"As a founding sponsor of the OASIS eTMF Technical Committee, SureClinical is excited to see the widespread industry adoption of OASIS open standards. As a provider of cloud-based eTMF applications, we are proud to partner in the development of this critical BioPharma initiative that accelerates delivery of new therapies globally by facilitating the paperless exchange of clinical trial content. We look forward to championing the OASIS eTMF Standard by implementing a compliant SureTrial® eTMF Cloud solution."
--Zachariah Schmidt, CEO, SureClinical

Additional information

OASIS eTMF Technical Committee
https://www.oasis-open.org/committees/etmf/

About OASIS:

OASIS is a non-profit, international consortium that drives the development, convergence and adoption of open standards for the global information society. OASIS promotes industry consensus and produces worldwide standards for cloud computing, content technologies, security, privacy, M2M, IoT, energy, and other areas. OASIS open standards offer the potential to lower cost, stimulate innovation, grow global markets, and protect the right of free choice of technology. OASIS members broadly represent the marketplace of public and private sector technology leaders, users, and influencers. The consortium has more than 5,000 participants representing over 600 organizations and individual members in 65+ countries.
http://www.oasis-open.org

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@CloudExpo Stories
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, discussed how research has demonstrated the value of Machine Learning in delivering next generation analytics to imp...
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
SYS-CON Events announced today that ReadyTalk, a leading provider of online conferencing and webinar services, has been named Vendor Presentation Sponsor at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. ReadyTalk delivers audio and web conferencing services that inspire collaboration and enable the Future of Work for today’s increasingly digital and mobile workforce. By combining intuitive, innovative tec...
Your business relies on your applications and your employees to stay in business. Whether you develop apps or manage business critical apps that help fuel your business, what happens when users experience sluggish performance? You and all technical teams across the organization – application, network, operations, among others, as well as, those outside the organization, like ISPs and third-party providers – are called in to solve the problem.
Amazon has gradually rolled out parts of its IoT offerings, but these are just the tip of the iceberg. In addition to optimizing their backend AWS offerings, Amazon is laying the ground work to be a major force in IoT - especially in the connected home and office. In his session at @ThingsExpo, Chris Kocher, founder and managing director of Grey Heron, explained how Amazon is extending its reach to become a major force in IoT by building on its dominant cloud IoT platform, its Dash Button strat...
Connected devices and the industrial internet are growing exponentially every year with Cisco expecting 50 billion devices to be in operation by 2020. In this period of growth, location-based insights are becoming invaluable to many businesses as they adopt new connected technologies. Knowing when and where these devices connect from is critical for a number of scenarios in supply chain management, disaster management, emergency response, M2M, location marketing and more. In his session at @Th...
Digital Initiatives create new ways of conducting business, which drive the need for increasingly advanced security and regulatory compliance challenges with exponentially more damaging consequences. In the BMC and Forbes Insights Survey in 2016, 97% of executives said they expect a rise in data breach attempts in the next 12 months. Sixty percent said operations and security teams have only a general understanding of each other’s requirements, resulting in a “SecOps gap” leaving organizations u...
What does it look like when you have access to cloud infrastructure and platform under the same roof? Let’s talk about the different layers of Technology as a Service: who cares, what runs where, and how does it all fit together. In his session at 18th Cloud Expo, Phil Jackson, Lead Technology Evangelist at SoftLayer, an IBM company, spoke about the picture being painted by IBM Cloud and how the tools being crafted can help fill the gaps in your IT infrastructure.
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his Day 2 Keynote at @ThingsExpo, Henrik Kenani Dahlgren, Portfolio Marketing Manager at Ericsson, discussed how to plan to cooperate, partner, and form lasting all-star teams to change t...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection. In his session at 18th Cloud Expo, Bradley Holt, a Developer Advocate with IBM Cloud Data Services, discussed...
SYS-CON Events announced today that Bsquare has been named “Silver Sponsor” of SYS-CON's @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. For more than two decades, Bsquare has helped its customers extract business value from a broad array of physical assets by making them intelligent, connecting them, and using the data they generate to optimize business processes.
There are several IoTs: the Industrial Internet, Consumer Wearables, Wearables and Healthcare, Supply Chains, and the movement toward Smart Grids, Cities, Regions, and Nations. There are competing communications standards every step of the way, a bewildering array of sensors and devices, and an entire world of competing data analytics platforms. To some this appears to be chaos. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Bradley Holt, Developer Advocate a...
The pace of innovation, vendor lock-in, production sustainability, cost-effectiveness, and managing risk… In his session at 18th Cloud Expo, Dan Choquette, Founder of RackN, discussed how CIOs are challenged finding the balance of finding the right tools, technology and operational model that serves the business the best. He also discussed how clouds, open source software and infrastructure solutions have benefits but also drawbacks and how workload and operational portability between vendors ...
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. Big Data at Cloud Expo - to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is...
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, wh...
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....